Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia

Perinatal Mortality Clinical Trial

Official title:

Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia: A Cluster-randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945931
• Other study ID #: SafeDeliveryApp
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: October 6, 2015
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: University of Copenhagen
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage. It is also the purpose to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation.

Description:

Abstract Hypothesis A safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage

A safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation

Intervention A safe delivery smartphone application with animated videos to improve clinical management during delivery will be introduced in the intervention clusters

Design Cluster randomized controlled trial with health facilities as the unit of randomization

Area Nole Kaba, Haru, Homa, Genji and Gimbie districts in Ethiopia

Population Pregnant women and their newborns delivered in a randomized health facility. For secondary outcomes health workers at randomized health facilities.

Sample size 77 health facilities with minimum 2 health workers per facility and 30 deliveries per health worker

Duration Pregnant women will be enrolled at delivery and followed to 7 days postpartum

Outcomes Primary outcomes are perinatal mortality and postpartum haemorrhage. Secondary outcomes are health workers knowledge and skills

Study time Data collection expected from September 2013 to September 2014

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3601
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women in active labor

Exclusion Criteria:

• None

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Maternal Death
• Maternal Mortality
• Perinatal Mortality

Intervention

Other:
• Safe Delivery Smartphone Application
The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries. The application is furthermore intended as a reference tool that could be used during clinical work for example for preparation before attending a birth, in a situation when a complication occurs, or for debriefing and self-evaluation after a complication. The application features four animated videos with clinical instructions of 3-8 minutes duration and written lists of essential obstetric drugs (indications, contraindications, dosage and administration and side effects) and essential equipment for a safe delivery.

Locations

Country	Name	City	State
Denmark	University of Copenhagen	København V

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality stratified according to gestational age and birth weight		Participants will be followed from delivery until 7 days postpartum	No
Other	Use of the Safe Delivery application (when, how much and by whom)		Participants will be followed during the 12 months trial period	No
Other	Process indicators of services provided		Participants will be followed from delivery until 7 days postpartum	No
Primary	Perinatal mortality (stillbirth and early neonatal death)		Participants will be followed from delivery until 7 days postpartum	No
Primary	Postpartum haemorrhage		Participants will be followed from delivery until two hours postpartum	No
Secondary	Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta		0, 6 and 12 months	No
Secondary	Health workers clinical performance in management of neonatal resuscitation		0, 6 and 12 months	No
Secondary	Health workers knowledge of management of active management of third stage of labour, manual removal of placenta and postpartum haemorrhage		0, 6 and 12 months	No
Secondary	Health workers knowledge of management of neonatal resuscitation		0, 6 and 12 months	No